Human Skin Test Model in Colostomists

NCT01918085 | Completed Results

• 1 other identifier: CP228
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.

Conditions

Colostomy Stoma

Outcome Measures

Primary Outcomes (1)

• Peel Force

  The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees. The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects.

  1 hour

Study Arms (2)

Peristomal skin

OTHER

The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin

Other: Hydrocolloid strip; Other: Strata strip

Pre-stripped abdominal skin

OTHER

The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin

Other: Hydrocolloid strip; Other: Strata strip

Interventions

Hydrocolloid strip OTHER

An adhesive strip made of hydrocolloid adhesive

Peristomal skin; Pre-stripped abdominal skin

Strata strip OTHER

An adhesive strip made of the Strata adhesive

Peristomal skin; Pre-stripped abdominal skin

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have given written informed consent.
• Be in the age of 45 to 75 years of age both extremes included.
• Have had a colostomy for at least 1 year.
• Has a colostomy with a diameter up to (≤) 40 mm.
• Have mental capacity to understand the study guidelines and questionnaires.
• Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
• Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
• Have a BMI between 20-30 kg/m2.
• Are willing to comply with investigation procedures.

You may not qualify if:

• Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
• Received radio- and/or chemotherapy within the last two months.
• Currently using or have within the last 3 weeks used topical steroid products or other skin prep products.
• on peristomal skin (injections and oral treatment are accepted).
• Have dermatological problems.
• Participating in other clinical studies or have previously participated in this test.
• Be a daily user of a convex base-plate.
• Are pregnant or breastfeeding.
• Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).

Sponsors & Collaborators

• Coloplast A/S: lead

Results Point of Contact

• Title: Henrik Sigaard Knoth
• Organization: Coloplast

dkhsk@coloplast.com

+ 45 4911 3469

Study Officials

• Tonny Karlsmark, MD

  Bispebjerg Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 7, 2013
• Study Start: April 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 12, 2014
• Results First Posted: March 12, 2014

Record last verified: 2014-01